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AZITHROMYCIN 200MG/5ML POWDER FOR ORAL SUSPENSION

Active substance(s): AZITHROMYCIN / AZITHROMYCIN MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Azithromycin 200 mg/5 ml
Powder for Oral Suspension
Azithromycin
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this or any other medicine.

Read all of this leaflet carefully before you start taking
this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

You should not use this medicine during pregnancy and when
you are breast-feeding unless your doctor has specifically
recommended it.
This medicine is excreted into human breast milk. So, you
should stop breastfeeding until 2 days after you have finished
taking this medicine.
Driving and using machines
Azithromycin is unlikely to impair the ability to drive and
operate machinery.

What is in this leaflet:
1. What Azithromycin is and what it is used for
2. What you need to know before you take Azithromycin
3. How to take Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other information

However, if side effects like dizziness, sleepiness or convulsions
occur, be careful when driving or operating machinery.
Azithromycin contains sucrose and aspartame
This medicine contains 3.7 gram sucrose per 5 ml suspension.
This should be taken into account in patients with diabetes
mellitus.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.

1. WHAT AZITHROMYCIN IS AND WHAT IT IS
USED FOR
Azithromycin is an antibiotic. It belongs to a group of
antibiotics called macrolides. It is used to treat infections
caused by bacteria.

This medicine contains aspartame. This is a source of
phenylalanine and may be harmful for people with
phenylketonuria.

This medicine is usually prescribed to treat:
• chest infections such as chronic bronchitis, pneumonia
• infections of the tonsils, throat (pharyngitis) and sinuses
• ear infections (acute otitis media)
• skin and soft tissue infections, with exception of infected
burn wounds
• urethra and cervix infections caused by chlamydia.

3. HOW TO TAKE AZITHROMYCIN

Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.

2. BEFORE YOU NEED TO KNOW BEFORE YOU
TAKE AZITHROMYCIN

Do not take Azithromycin if you are allergic (hypersensitive)
to:
• azithromycin
• erythromycin
• other macrolide or ketolide antibiotic
• any of the other ingredients of this medicine (listed in section 6).

The dosage for the treatment of sore throat is an exception.
Your doctor may prescribe a different dosage.

Warnings and precautions
Talk to your doctor or pharmacist before taking Azithromycin if
you have:
• Liver problems: your doctor may need to monitor your liver
function or stop the treatment.
• Kidney problems: if you have severe kidney problems, the
dose may have to be adjusted.
• Nervous (neurological) or mental (psychiatric) problems
• Heart problems such as a
- weak heart (heart failure),
- very slow heart rate,
- irregular heart beat, or
- a condition called “long QT syndrome” (found by an
electrocardiogram) since azithromycin may increase the
risk of abnormal heart rhythm.
• Low potassium or magnesium levels in your blood
• Myasthenia gravis, a certain type of muscle weakness

Children weighing less than 45 kg:
Azithromycin is not suitable for use in children under the age
of 1 year.
Azithromycin is taken as a 3 or 5 day course. The daily
amount is worked out according to the weight of the child.
The following tables provide a guide to usual doses:
3-day therapy

Other medicines and Azithromycin
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes any
medicines obtained without a prescription.
It is especially important to mention that you take:
• Theophylline (used to treat asthma): the effect of
theophylline may be increased.
• Blood-thinning medicines, such as warfarin,
phenprocoumon:
concomitant use may increase the risk of bleeding. Your
doctor may need to monitor more often the blood clotting
parameters when Azithromycin is also being used.
• Ergotamine, dihydroergotamine (used to treat migraine):
ergotism (i.e. itching in the limbs, muscle cramps and
gangrene of hands and feet due to poor blood circulation)
may occur. Concomitant use is therefore not recommended.
• Cyclosporin (used to suppress the immune system to
prevent and treat rejection of an organ or bone marrow
transplant): if concomitant use is required, your doctor will
check cyclosporine levels in your blood and may adapt the dose.
• Digoxin (used for heart failure):
concomitant use may increase digoxin levels. Your doctor
will check its levels in your blood.
• Antacids (used for indigestion):
may make azithromycin less effective when used
concomitantly, see section 3.
• Cisapride (used for stomach problems), terfenadine (used
to treat hay fever), pimozide (used in some mental
diseases), citalopram (used in depression),
fluoroquinolones (antibiotics such as moxifloxacin and
levofloxacin, used in bacterial infections):
concomitant use with azithromycin may cause heart
disorders, therefore is not recommended.
• Certain medicines for irregular heart beat (called
anti-arrythmics, such as quinidine, amiodaron, sotalol).
Concomitant use is not recommended.
- Zidovudine (used to treat HIV infections): concomitant use
can increase the risk of side effects.
• Nelfinavir (used to treat HIV infections):
concomitant use may increase the risk of side effects.
• Alfentanil (used for narcosis) or astemizol (used to treat
hay fever): concomitant use with azithromycin may increase
the effect of these medicinal products.
• Rifabutin (used to treat tuberculosis):
Your doctor may check your blood and blood levels of the
medicines.
• Statins (such as atorvastatin, used to lower lipids in blood):
concomitant use may cause muscle disorders.

Weight

Day 1 - 3

10 kg

2.5 ml (100 mg)

12 kg

3 ml (120 mg)

14 kg

3.5 ml (140 mg)

16 kg

4 ml (160 mg)

17 - 25 kg

5 ml (200 mg)

26 - 35 kg

7.5 ml (300 mg)

36 - 45kg

10 ml (400 mg)

> 45 kg

12.5 ml (500 mg)

5-day therapy
Weight

Day 1

Day 2 - 5

10 kg

2.5 ml (100 mg)

1.25 ml (50 mg)

12 kg

3 ml (120 mg)

1.5 ml (60 mg)

14 kg

3.5 ml (140 mg)

1.75 ml (70 mg)

16 kg

4 ml (160 mg)

2 ml (80 mg)

17 - 25 kg

5 ml (200 mg)

2.5 ml (100 mg)

26 - 35 kg

7.5 ml (300 mg)

3.75 ml (150 mg)

36 - 45kg

10 ml (400 mg)

5 ml (200 mg)

> 45 kg

12.5 ml (500 mg)

6.25 ml (250 mg)

Patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems
as your doctor may need to alter the normal dose.
Dosage for elderly
For elderly the same dosage as for adults applies.
Take this medicine once daily. You may take it with or
without food.
A bitter after-taste can be avoided by drinking fruit juice directly after swallowing.
Taking Azithromycin with medicines for indigestion
If you need to take a medicine for indigestion, such as an
antacid, take Azithromycin at least one hour before or two
hours after the antacid.
How to measure the dose
A 10 ml syringe marked at each 0.25 ml is provided with this
medicine. It comes with an adaptor which fits onto the bottle.
To measure the medicine:
• Shake the bottle
• Put the adaptor into the mouth of the bottle
• Put the end of the syringe into the adaptor
• Turn the bottle upside-down
• Pull the plunger to measure the dose you need
• Turn the bottle upright, remove the syringe, leave the
adaptor on the bottle and close the bottle.

Azithromycin with food and drink
This medicine may be taken with or without food.

Ask you doctor or pharmacist if you need advice on how to
measure out the medicine.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be

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Adults and children weighing more than 45 kg:
Azithromycin is taken as a 3 or 5 day course
• 3 day course: Take 12.5 ml (500 mg) once each day
• 5 day course:
- Take 12.5 ml (500 mg) on Day 1
- Take 6.25 ml (250 mg) on Days 2, 3, 4 and 5
For urethra and cervix infections caused by Chlamydia, it is
taken as a 1 day course:
• 1 day course: 25 ml (1,000 mg).

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• abnormal liver function
• sensitivity to sunlight.

Giving the medicine using the syringe
• Make sure the child is supported in an upright position
• Put the tip of the syringe carefully into the child's mouth.
Point the tip of the syringe towards the inside of the cheek
• Slowly push down the plunger of the syringe: Do not squirt it
out quickly. The medicine will trickle into the child's mouth
• Allow the child time to swallow the medicine.

Not known (frequency cannot be estimated from the
available data)
• Low level of red blood cells which can make the skin pale
yellow and cause weakness or breathlessness
• Reduction in blood platelets, which increases risk of
bleeding or bruising
• Severe allergic reaction
• Aggression, anxiety, severe confusion, hallucination
• Fainting, fits, decreased skin sensitivity, feeling hyperactive,
disturbed sense of smell, loss of sense of smell or taste,
muscle weakness (myasthenia)
• Poor hearing, deafness or ringing in the ears
• Arrhythmia, abnormal electrocardiogram (ECG)
• Low blood pressure
• Tongue discolouration
• Hepatic failure, serious liver inflammation
• Joint pain
• Renal failure, renal inflammation.

How to prepare this medicine
A doctor, nurse or pharmacist will prepare this medicine for
you. To open the medicine bottle, you need to press the
childproof top down and then turn it.
If you need to prepare this medicine yourself, you should
shake the dry powder loose and add the right amount of cold
water. With the 10 ml syringe you can measure the right
amount of water. The right amount of water depends on the
bottle size and is provided below:
• For 15 ml suspension (600 mg) add 8.0 ml of water
• For 20 ml suspension (800 mg) add 10.5 ml of water
• For 22.5 ml suspension (900 mg) add 11 ml of water
• For 30 ml suspension (1,200 mg) add 15 ml of water
• For 37.5 ml suspension (1,500 mg) add 18.5 ml of water

The following side effects have been reported in prophylaxis
and treatment against Mycobacterium Avium Complex MAC):

Shake the bottle well as soon as you have added the right
amount of water. You only need to prepare the suspension
once, at the beginning of your course.

Very common side-effects (may affect more than 1 in 10
people):
• Diarrhea
• Abdominal pain
• Feeling sick (nausea)
• Loose wind (flatulence)
• Abdominal discomfort
• Loose stools

If you take more Azithromycin than you should
If you take too much you may feel or be sick. You also may
experience other side effects such as temporary deafness and
diarrhoea. Tell your doctor or talk to your nearest hospital
casualty department immediately. If possible, take your
medicine with you to show the doctor what you have taken.
If you forget to take Azithromycin
If you forgot to take a dose, take it as soon as possible. Then
go on as before. Do not take more than one dose in a single day.
If you stop taking Azithromycin
Always keep taking the oral suspension until the course is
finished, even if you feel better. If you stop taking the oral
suspension too soon, the infection may come back. Also, the
bacteria may become resistant to the medicine and will then
be more difficult to treat.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

Uncommon side-effects (may affect up to 1 in 100 people):
• Reduced sense of touch (hypoesthesia)
• Hearing impairment or ringing in your ears
• Abnormality of the rhythm or rate and awareness of the
heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth and genitals,
which may be caused by Stevens-Johnson syndrome
• Allergic skin reactions such as being sensitive to sunlight,
red, flaking and swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise)

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious side effects:
If you have any of the following symptoms of a severe
allergic reaction stop taking this medicine and tell your
doctor immediately or go to the casualty department at
your nearest hospital:
• Sudden difficulty in breathing, speaking and swallowing
• Swelling of the lips, tongue, face and neck
• Extreme dizziness or collapse
• Severe or itchy skin rash, especially if this shows blistering
and there is soreness of the eyes, mouth or genital organs.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow Card
Scheme: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.

If you experience any of the following side effects contact
your doctor as soon as possible:
• Diarrhea that is serious, lasts a long time or has blood in it,
with stomach pain or fever. This can be a sign of a serious
bowel inflammation that can rarely happen after taking
antibiotics
• Yellowing of the skin or whites of the eyes caused by liver
problems
• Inflammation of the pancreas, which causes severe pain in
the abdomen and back
• Increased or reduced urine output, or traces of blood in your urine
• Skin rash caused by sensitivity to sunlight
• Unusual bruising or bleeding
• Irregular heart beat.
These are all serious side effects. You may need urgent
medical attention. Serious side effects are uncommon (may
affect up to 1 in 100 people), rare (may affect up to 1 in 1,000
people), or the frequency cannot be estimated from the
available data.

5. HOW TO STORE AZITHROMYCIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the package after "Do not use after:" or “Exp.:”. The expiry
date refers to the last day of that month.
Do not store the unopened bottle with dry powder at a
temperature above 30°C.
Do not store Azithromycin suspension at a temperature above
25°C.
Do not use the reconstituted Azithromycin suspension later
than 10 days.
If you get the suspension from the pharmacy: do not use later
than 10 days after the date of issue. The date of issue is on
the pharmacy’s label.

Other possible side effects:

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

Very common side effects (may affect more than 1 in 10 people):
• diarrhea.
Common side effects (may affect up to 1 in 10 people):
• headache
• nausea, vomiting, abdominal pain
• changes in number of white blood cells (low numbers of
lymphocytes, higher number of eosinophils, higher number
of basophils, monocytes and neutrophils
• decreased blood bicarbonate (what indicates too much
acidic substances in blood).

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

What Azithromycin contains
• The active substance is azithromycin monohydrate
equivalent to 200 mg azithromycin per 5 ml
• The other ingredients (additives) are: sucrose, xanthan gum
(E415) hydroxypropylcellulose, anhydrous trisodium
phosphate, anhydrous colloidal silica, aspartame (E951),
cream caramel flavour, titanium dioxide (E171).

Uncommon side-effects (may affect up to 1 in 100 people):
• Yeast and bacterial infections especially of the mouth,
throat, nose, lung, stomach, bowel and vagina
• Changes in number of white blood cells (low numbers of
leukocytes, low number of neutrophils, higher number of
eosinophils)
• Swelling, allergic reactions of various severity
• Loss of appetite (anorexia)
• Nervousness, drowsiness, sleeplessness, dizziness, taste
disturbance, tingling or numbness of the hands and/or feet
• Visual disturbances
• impaired hearing, spinning sensation (vertigo)
• Pounding heart beat
• Feeling of intense heat with sweating and rapid heartbeat
(hot flush)
• difficulty breathing, nose bleeds
• constipation wind, indigestion, inflammation of the stomach,
difficulty in swallowing, bloating, dry mouth, eructation,
mouth sores, increased formation of saliva
• Skin rash, itching, hives, skin inflammation, dry skin, sweating
• Bones and joint inflammation, muscle, back and neck pains
• difficulty and pain when passing urine, kidney pain
• uterine bleeding, testis disorder
• skin swelling, weakness, generally feeling unwell, tiredness,
swelling of the face, chest pain, fever, pain, swelling of
extremities
• abnormal laboratory test values (e.g. blood, liver and kidney
function test results).
• post procedural complications

What Azithromycin looks like and contents of the pack
Azithromycin is a white or off-white crystalline powder.
After reconstitution a white to off white coloured, homogenous
suspension exists.
Azithromycin 200 mg/5 ml Powder for Oral Suspension is
available in HDPE bottles with a PP/PE closure with retaining
ring containing 15, 20, 22.5, 30 and 37.5 ml after
reconstitution.
A plastic dosage syringe (10 ml), graduated in 0.25 ml
divisions is also included.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation Holder: Sandoz Ltd, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Sandoz S.R.L., Str. Livenzeni nr. 7A, 540472 Targu Mures,
Romania or Lek Pharmaceuticals d.d., Verovškova 57,
1526 Ljubljana, Slovenia or Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.

Rare side-effects (may affect up to 1 in 1,000 people):
• agitation

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Common side-effects (may affect up to 1 in 10 people):
• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness (paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

This leaflet was last revised in 05/2015.

Artwork Proof Box
Ref: V028: change in-process limits and fill volume of FP+Nat Phase
Proof no.
012.1

Date prepared:
02/06/2015

Colours:
Black
Dimensions: 200 x 520 mm

Font size:
9pt
Fonts:
Helvetica

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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